SPT implemented Nexa3D’s Freeform Injection Molding (FIM) technology to help customers shorten time-to-market on complex medical devices in demanding medical-grade materials and to expand on the range of materials that can be quickly and reliably used in prototyping and early device test manufacturing.

Based on input collected from the first two iterations, the design of the silicone part was approved and manufacturing of a metal tool was initiated with full confidence of part moldability and performance. The in-house tool shop built the final metal tooling in four weeks without iterations.

The patented FIM process uses high-speed Nexa3D printers and xMOLD resin to print injection molding tools that are compatible with thousands of off-the-shelf injection molding materials, including reinforced high-performance feedstocks. The process reduces design, iteration, and validation cycles using end-product materials to a matter of hours rather than weeks.

Editor in chief of PlasticsToday since 2015, Norbert Sparrow has more than 30 years of editorial experience in business-to-business media. He studied journalism at the Centre Universitaire d'Etudes du Journalisme in Strasbourg, France, where he earned a master's degree.

Medical device manufacturers are tasked with developing elaborate test protocols to ensure that the product in development is safe and meets essential requirements. If these tests are conducted late in the development process, the more onerous and risky they become. SPT Vilecon often works with silicone, a material that is extensively used in medical applications because of its chemical resistance, mechanical performance, and biocompatibility. However, silicone parts are notoriously difficult to prototype and test, since most grades need to be injection molded to achieve their full performance potential, said the company. FIM enabled SPT Vilecon to offer an alternative to a customer developing an intravenous (IV) silicone product — the use of 3D-printed tooling to perform early design and material verification at a fraction of the cost of conventional methods.

Robomold Plastic Solutions reports that it has partnered with AMS, a manufacturer of innovative robotics for plastics processors, and will be the exclusive provider of the robotic plastic molding technology for North America. A division of Gemini Inc., Robomold offers total manufacturing solutions for complex and high-value plastic parts and assemblies with its suite of rotational molding and thermoforming equipment.

Robust and valid prototyping and verification are key to minimizing cost, time, and risk factors in developing medical devices, said SPI Vilecon. FIM is a new toolbox for medical device companies seeking to accelerate their innovation and obtain early verification of part performance and moldability, added the company.

The 3D-printed molds for the first and second iterations cost less than €2,000 combined. And the technology enabled a two-day design cycle, which is more than 90% faster than conventional metal tooling.

Through the partnership, Robomold will be the exclusive provider of AMS’ robotic plastic molding technology in North America.

Robomold’s exclusive robotic rotational molding technology offers an advanced technical solution for unique requirements, said the company, including the reliable, repeatable production of high-tolerance parts.

SPT Vilecon said it has begun expanding the range of injection mold prototyping with silicone, metal, and ceramic materials to provide medical device manufacturers with an even wider selection of product development and verification services.

Design input collected from the first tests was integrated in a second iteration that took only a couple of hours to complete. By contrast, conventional metal tooling would have taken more than six weeks to design and procure, and the adjustments needed for the second iteration would have taken an in-house tool-shop a week to complete.

ITAR-certified Robomold Plastic Solutions provides product engineering support, tooling, and testing to demanding industry quality standards, including Mil Spec 810, Mil Spec 648, and IPX.

Certified to ISO 13485, Denmark-based SPT Vilecon describes itself as a fully integrated provider of development and manufacturing services to the medical device industry. It offers in-house tool making and injection molding along with other manufacturing services to companies in northern Europe.

“Robomolding offers greater flexibility and control in the design and production of rotationally molded parts,” Sauber explained to PlasticsToday. “We can also automate parts of the process to help reduce overall manufacturing time and improve cycle times. Utilizing individual heating elements that are designed into the aluminum tools, robomolding allows for precise heating of different zones. Electric heating elements also eliminate the need for large heating and cooling chambers, thereby reducing energy consumption, creating a smaller footprint, and providing more-consistent, quality parts off the tool,” said Sauber.

A supplier of development and manufacturing services to medical device OEMs used Freeform Injection Molding from Nexa3D to accelerate time-to-market and slash prototyping costs for a complex silicone-based IV device. SPT Vilecon explained the process in a recent press release.

Freeform Injection Molding technology from Nexa3D compresses design, iteration, and validation cycle times into a matter of hours rather than weeks.

Until she retired in September 2021, Clare Goldsberry reported on the plastics industry for more than 30 years. In addition to the 10,000+ articles she has written, by her own estimation, she is the author of several books, including The Business of Injection Molding: How to succeed as a custom molder and Purchasing Injection Molds: A buyers guide. Goldsberry is a member of the Plastics Pioneers Association. She reflected on her long career in "Time to Say Good-Bye."

“Robomold Plastic Solutions is a uniquely qualified manufacturing partner with capabilities in part and tooling design, production and value-added modifications, and final testing and certifications,” said Sauber. “The addition of robotic molding furthers our ability to bring the most complex molded plastic designs to reality.”

The process also enables Robomold to manufacture more precise parts with greater complexity by closely controlling the heat distribution, allowing for thinner, more consistent wall thicknesses and reduced overall weight. This ability to better control wall thickness is a distinct advantage in that it allows for designed-in wall thickness variation in specific areas. Additionally, multi-layer parts are possible and practical with a wider range of polymers.

Injection-molded silicone parts were produced within two days, allowing early verification of key design and performance aspects.

Robotic plastic molding delivers high-precision heat and material control, allowing part designs to benefit from reduced materials consumption and finished part weight without sacrificing strength or durability. In-mold layering of different compounds and coatings enhance the technical properties of the most complex and high-value designs, explained Dan Sauber, Senior Product Manager, Robomold Plastic Solutions and Gemstar Manufacturing, a maker of custom hard cases.